Summaries of health policy coverage from major news organizations

Senior NIH Official Resigns, Citing New Conflict-Of-Interest Policy

James Battey, chair of the NIH Stem Cell Task Force and director of the NIH National Institute on Deafness, recently announced that he will retire in September, saying that the agency's new conflict-of-interest rules posed an "insurmountable problem" for him, the Washington Postreports.

Battey said, "I manage a family trust ... which supports the education of my father's seven grandchildren, and it contains assets I'm told I'd have to divest. That would cost a lot of money, and I can't do that to my family." Battey, who has been at NIH for more than 20 years, has applied to be president of the California Institute for Regenerative Medicine (Rosenwald/Weiss, Washington Post, 4/2).

Rules

Under the rules, NIH employees will be barred from entering outside consulting agreements with pharmaceutical companies, hospitals, health insurers and health care providers. The guidelines also will mandate that about 6,000 top NIH employees cannot hold stock in pharmaceutical or biotechnology companies and require current stockholders in the group to sell their shares. NIH Deputy Director Raynard Kington recently said that the agency's 1,300 temporary research fellows can continue to hold biomedical stocks. He said the fellows still will be required to disclose their financial information to NIH on an annual basis.

Kington added that the fellows, who can work at NIH for as long as four years, will be examined on "case-by-case analyses" to prevent conflicts of interest. In addition, permanent staff will be given an additional six months -- until Oct. 3 -- to divest their biomedical holdings, Kington wrote in the memo. Other agency employees must divest by the same date any holdings that exceed $15,000 in value for a particular company.

NIH officials said they do not plan to change the policy's provision on accepting consulting fees from companies. The new policy, announced Feb. 1 by NIH Director Elias Zerhouni, will become final this month (California Healthline, 3/17).

Memo

A group of senior agency scientists, in a memo to NIH employees on Friday, detailed a legal opinion they recently received that clarifies the new rules. The memo states, "Basically [the decision] means anything NIHers do outside -- whether getting paid for it or not, from singing in a jazz group to selling art or jewelry, from volunteering at charity organizations to membership in a school or community organization to developing their own small business completely unrelated to biomedical science -- requires prior NIH approval. We find this very disturbing. It is intrusive and scary. It suggests the NIH owns our lives away from work."

In addition, biotech companies have said that the rules have prompted NIH scientists to withdraw from advisory boards and consulting deals. Margaret Kripke, chief academic officer for the M.D. Anderson Cancer Center, an organization that "frequently recruits" NIH employees, said that consulting agreements put physicians "on the front lines of new drugs being developed that we can make available to our patients."

Jerry Feigen, former director of the Macklin Center for Entrepreneurship at Montgomery College, who teaches a business class at NIH featuring lectures by local venture investors, said, "A lot of these researchers really want to understand the commercial side of their work. If the NIH wants to land the brightest brains, they have to come to grips with helping do-good researchers understand the commercial side of science."

NIH Response

Agency officials have said that concerns about the impact on private industry are "somewhat exaggerated," the Post reports. They noted that researchers can continue to work with companies as part of their official NIH duties and under agreements in which each side provides resources to develop products. NIH employees also will still be entitled to up to $150,000 annually in royalties if companies license their discoveries and develop a product.

Other Departures

Battey is the fourth "high-profile" researcher and the first institute director to announce his resignation since the new rules were announced, the Post reports. National Cancer Institute pathologist Lance Liotta recently announced plans to leave the agency. Liotta is establishing a research center at George Mason University. Researchers at George Mason and many other academic institutions are encouraged to consult with private companies, according to Vikas Chandhoke, George Mason's associate dean for research (Washington Post, 4/2).

David Schwartz, a physician nominated to become the new director of the National Institute of Environmental Health Science at NIH, has indefinitely postponed assuming his role because of concerns about the conflict-of-interest guidelines (California Healthline, 3/30).

H. Bryan Brewer, a vascular-disease specialist at the National Heart, Lung and Blood Institute, and Emanuel Petricoin, who is based at NIH but is employed by FDA, also have announced plans to leave the agency (California Healthline, 3/10).